UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-02-25 for UNK manufactured by Unk.

Event Text Entries

[367757] Pt having thermal ablation performed for menorrhagia. Surgeon unable to get pressure with ablation device. Hysteroscope inserted. Perforation identified and repaired.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 513288
• MDR Report Key: 513288
• Date Received: 2004-02-25
• Date of Report: 2004-02-19
• Date of Event: 2004-02-04
• Date Facility Aware: 2004-02-13
• Report Date: 2004-02-19
• Date Reported to FDA: 2004-02-19
• Date Added to Maude: 2004-03-01
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: UNK
• Generic Name: CERVICAL DILATOR
• Product Code: MCR
• Date Received: 2004-02-25
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 502302
• Manufacturer: UNK
• Manufacturer Address: UNK UNK *

Device Sequence Number: 2

• Brand Name: UNK
• Generic Name: UTERINE SOUND
• Product Code: HHM
• Date Received: 2004-02-25
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 2
• Device Event Key: 502303
• Manufacturer: UNK
• Manufacturer Address: UNK UNK UNK *

Device Sequence Number: 3

• Brand Name: UNK
• Generic Name: INTRAUTERINE ENDOMETRIAL ABLATION UNIT
• Product Code: LPB
• Date Received: 2004-02-25
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 3
• Device Event Key: 502305
• Manufacturer: UNK
• Manufacturer Address: UNK UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2004-02-25